Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislation

We welcome the Commissions initiative to revise the EU rules for medical devices and in vitro diagnostics and appreciate the opportunity to participate. We specifically recommend the removal of the Chapter II, Article 5.5.d the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent…

We warmly welcome the opportunity to provide feedback as part of this consultation process, even if we would like this opportunity to have been opened earlier, as many manufacturers have been struggling with the challenges of MDR/IVDR implementation for years.

Filed in German · English published by the European Commission

We welcome the rationale of the IVDR. However, the IVDR was drawn up without taking into account the specific challenges faced by SMEs. Both human and financial costs quickly exceed the performance of SMEs and lead to products being withdrawn from the market or distributed in the non-European market.

Filed in German · English published by the European Commission

We support the objective of the IVDR to ensure greater safety and transparency for patients. However, as a human agent institute, the implementation of the IVDR is a major challenge. The use of in-house IVDs is ubiquitous in diagnostics, in particular because of the particularities of rare diseases, which can often be adequately investigated only with dedicated in-house IVDs.

Filed in German · English published by the European Commission

We are pleased to submit our response to the Call for Evidence on the targeted revision of the EU rules for medical devices and in vitro diagnostics. In terms of potential simplification and burden reduction for economic operators, we recommend continuing the approach taken for decades by EU medical devices legislation: integrating substantial requirements from other EU legislation to avoid double certification.

We appreciate the opportunity to provide feedback on the revision of MDR. Our suggestions regarding MDR is as follows. 1. It is suggested to clarify which specific devices each type of WET device refers to. Different people may have different understandings of the list of devices listed in the second subparagraph of Article 52(4) and in point (b) of paragraph 6 of Article 61.

The current regulation, in particular Regulations (EU) 2017/745 and (EU) 2017/746, has brought significant challenges, in particular for SMEs and manufacturers of low-risk devices. The unpredictability of certification processes, the limited capacity of notified bodies and the administrative burden have led to situations where critical devices are at risk of exit from the market.

Filed in Finnish · English published by the European Commission

Dear Members of the Commission, on behalf of EIGA -European Industrial Gases Association, we wish to express our full support for the initiative to revise the MDR Regulation. EIGA is a safety and technically oriented organization representing the vast majority of European and also non-European companies producing and distributing industrial, medical and food gases.

As has been pointed out, the cost of certification has risen exponentially, and commercialisation of some devices may have little to no ROI. Additionally : 1. Redundancies in documentation : Many documents repeat the same thing over and over, and in some cases, this leads to non-compliances that don't have any impact on the product safety.

Working in IVDR the requirements to do analytical performance evaluation is very unclear. The IVDR places high demands on verification of analytical performance but leaves the interpretation open regarding study design, scope, number of samples and acceptance criteria.

The Commission's initiative to simplify EU regulations for medical devices and the opportunity to make proposals in this regard are welcome. As a long-time consultant to the medical device industry, particularly small and medium-sized manufacturers and start-ups, I consider the following simplifications to be essential and long overdue: - Fast-track procedures and simplified conformity assessment for innovative…

The new regulatory framework / MDR is not reducing the administrative burden nor is it supporting cost-efficiency, especially for companies dealing with simple and long experineced class I and IIa products. Pateint safety in not increased by the heavy documentation burden. Micro-companies as ourselves are most probably to be forced into bankruptcy,and the market supply will be eroded and become more expensive.

The large number of additional interpretative papers, FAQs, MDCGs, etc. go beyond the framework and can no longer be understood for the majority of medical firms in Europe. These additional documents are interpreted precisely by the notified bodies (although the opposite is on the papers), as is the case with a legislative or regulatory text.

Filed in German · English published by the European Commission

Thank you for providing the opportunity to give feedback. We are an SME that develops and manufactures IVD devices. Our product range covers all risk classes, from D to A, and we have been working with a Notified Body for years. We are concerned about the classification of lower-risk IVD devices by companies that have never worked with a Notified Body.

We are a company with one SaMD class IIa. We would like to highlight the challenges of the certification process under MDR: - The fact is, compliance requires integrating the MDR with numerous separate guidance documents. Our experience is that navigating this feels like a massive maze, creating a constant concern that we might be missing a critical detail.

BrosMed is a leading medical device manufacturer specializing in cardiovascular and peripheral vascular intervention technologies, supporting global healthcare providers and patients to advance medical innovation. We welcome the European Commissions efforts to enhance the practicality of the MDR (EU 2017/745) and IVDR (EU 2017/746) and offer the following recommendations to address key operational challenges: 1.

The procedure in the MDR is complicated rules and even more documentation to keep track of, at the same time this does not make the product better or safer because the manufacturing method of our product has not changed. It is the same process all the time and there is no other method to change this.

Filed in Swedish · English published by the European Commission

As a SME with only one product we struggle to cope with the fact that the product we safely have produced and sold for more than 20 years changes classification from Is to (suggested by competent authority ) IIb. The result will not be a safer product for the consumer - only a more expensive product since we need to adopt to a documentation and reviews by NB that are both time consuming and costly.

The introduction of the MDR was intended to increase the safety of medical devices. This goal would be defensible if the measures introduced actually improved safety in proportion to their economic cost (marginal benefit versus marginal cost). In reality, however, most medical devices have not changed in their fundamental mode of action, structure, or materials.

MDR/ISO13485 compliance and audits are at for sure in the top 3 challenges to run a small medical device company. I am not in this feedback questioning the regulations. They typically are included for a reason. The challenge is the implementation of the process. The one size fits all approach.

There are difficulties in cooperation between companies of different sizes, as the larger firm is often unwilling to provide the smaller firm with the detailed documents required under the MDR to place products on the market. We have noticed that larger firms in smaller firms (customers) lose interest as soon as they are asked to provide the customer with documents (e.g.

Filed in German · English published by the European Commission

While many people here have shared thoughtful feedback, we think that the elephant in the room is being overlooked: The MDR is fundamentally broken, and the EU is failing in its role in nearly every aspect. We (OpenRegulatory) are a consultancy and eQMS software provider, focusing mainly on startups; arguably, there might be no other company in the EU which has been as exposed as we have to the struggles of…

Feedback on: Medical devices and in vitro diagnostics targeted revision of EU rules Problem / Challenge Current EU regulatory frameworks treat targeted oncological therapies and their companion diagnostics as two separate products, converging only late in development. This fragmentation creates inefficiencies: duplicated assessments, delays, and increased costs.

Feedback on: Medical devices and in vitro diagnostics targeted revision of EU rules - Incentives for CDx in Rare and Paediatric Cancers Problem / Challenge Targeted therapies for rare and paediatric cancers benefit from dedicated EU incentives: Regulation (EC) 141/2000 (Orphan Medicines) protocol assistance, reduced/waived fees, centralised procedure, and up to 10-year market exclusivity.

Feedback on: Medical devices and in vitro diagnostics targeted revision of EU rules Guidance for CDx Development Problem / Challenge Many companion diagnostics (CDx), like many innovative targeted therapies, are initially developed by small and medium-sized enterprises (SMEs).

With regard to the Medical Devices Regulation (EU) 2017/745 (MDR), we consider some existing rules to be excessively burdensome and inappropriate: We consider the obligation to re-certify products in particular in risk class III to be disproportionately burdensome. Risk class III products are in any case closely monitored continuously, both clinically and regulatoryly.

Filed in German · English published by the European Commission

My opinion concerns class I medical devices intended for the improvement of life at home and at low risk, such as products intended for the transfer and handling of patients. The compilation of technical dossiers is problematic for the biological and clinical evaluation parts.

Filed in French · English published by the European Commission

The Council of European Dentists (CED) welcomes the Commissions envisioned review of the rules for medical devices. We fully share the goal of ensuring patient safety while supporting innovation and competitiveness. But in practice, the way the Medical Devices Regulation (MDR) is being implemented is causing serious problems.

As set out in our earlier submission, the European Hearing Instrument Manufacturers Association (EHIMA) welcomes the opportunity to contribute to the European Commissions stakeholder consultation on the revision of the Medical Device Regulation (MDR). EHIMA urges the European Commission to revise MDR implementation to ensure efficiency, consistency, and risk-based regulation.

The Bavarian Ministry of the Environment and Consumer Protection continues to welcome the evaluation and revision of the existing EU rules on medical devices (MDRs) and in vitro diagnostic medical devices (IVDRs) to ensure that only safe and effective devices are on the EU market. The objective of increasing patient safety and ensuring a high level of health protection is fully shared.

Filed in German · English published by the European Commission

1.We suggest introducing a dynamic risk classification mechanism in regulations and setting priority and simplifying the approval process for products that are in short supply or of significant public health importance and have passed IVDD certification, in order to shorten the approval time.

Further to our feedback provided to the previous Have Your Say: EU rules on medical devices and in vitro diagnostics targeted evaluation, MED-EL would like to add an additional point: MED-EL is aware of a huge discrepancy between the timelines for issuance of FSCs from differing CAs. This can range from days in some member states to months in others. In one circumstance it has taken over 4 months (and counting).

Comments and Suggestions Regarding the Development of MDR As a small MedTech company, we have faced significant challenges in continuing our commercial activities during the MDR certification process. Almost all of our time and resources over the past two years have been dedicated to preparing the extensive documentation required for MDR approval.

I am a laboratory and QM manager in the laboratory of a great pathology. We are accredited in accordance with DIN EN/ISO 17020:2012 and therefore also comply with DIN EN ISO 15189:2024. So we are already regulated and regularly assessed by the accreditation body. This accreditation should be recognised in order to be allowed to use IH-IVD.

Filed in German · English published by the European Commission

To accelerate innovation while maintaining the high level of patient safety, we propose to adapt the certification process for stand-alone software medical devices (under Rule 11): Sample certification: Instead of the mandatory certification of each software product and individual updates by a notified body, a system of risk-based sample testing should be introduced.

Filed in German · English published by the European Commission

Recent research highlights how inconsistencies in the interpretation of the EU Medical Device Regulation (MDR) create unnecessary burdens for manufacturers, especially for medium-risk devices. The study shows that while MDR aims to enhance patient safety by requiring sufficient clinical evidence, the lack of clarity on what qualifies as such evidence has led to divergent practices among notified bodies.

We welcome the Commissions initiative to simplify EU rules for medical devices and in vitro diagnostics, while ensuring both patient safety and innovation. Based on our experience with the current Medical Device Regulation (MDR), we would like to highlight the following issues and recommendations: 1.

The transition to MDR (EU) 2017/745 places an enormous burden on manufacturers of medical devices with proven technologies, in particular for class IIb and III surgical implants. The requirements are very complex, unclear and the costs and time needed to re-mark the CE marking have increased sharply.

Filed in German · English published by the European Commission

Implementing future requirements for in vitro diagnostic medical devices will entail considerable costs for our manufacturers. This could have the following consequences: 1. The discontinuation of further devices, which can lead to a reduction in diagnostic diversity and thus to a deterioration of patient care. 2.

Filed in German · English published by the European Commission

Many experiences were shared on this platform, with which we wholeheartedly agree as -Subjective assessment of technical documentation due to unclear specifications and interpretation by the technical experts of the notified bodies, who in turn refer to the strictness of the examinations by the ZLG. -The requirements are interpreted differently by different authorities within the EU.

My company is a manufacturer of in vitro diagnostic medical devices, agglutination latex tests. So far, under the previous Directive 98/79/EC, our devices have not been subject to certification due to their low risk to patients and users. These are screening tests the results of which, according to the instructions, must be confirmed by further examinations.

Filed in Polish · English published by the European Commission

For blood pressure cuffs and similar low-risk medical devices that only contact intact human skin, validation based on scientific literature data should be sufficient, with the user manual containing only references to the disinfectant manufacturer's instructions. Scientific Justification 1.

Experience from everyday research shows that the new regulations defining other clinical investigations in accordance with Article 70 MDR have created a major hurdle for research projects. This poses considerable practical challenges for researchers. According to Article 62(4) MDR in conjunction with Annex XV, exploratory studies must also meet almost all of the requirements for clinical trials.

We are a small company developing digital solutions for rare and complex conditions (e.g. phantom limb pain, CRPS, complex hand injuries). Our products combine hardware (VR systems) and software and are directly affected by the MDR. From our perspective, five main issues should be addressed: 1. Classification uncertainty Current practice is inconsistent.

According to standard of ISO 10993-1, some devices of class I, IIa are classified as C-long term contact duration devices, which needs tests like Acute systemic toxicity and Subacute toxicity, ect. The guide about the biocompatibility tests that are suitable for I, IIa, IIb, III devices is needed. Or guidances about biocompatibility for the devices with some common used materials.

As an enterprise specialising in the development and production of IVD products, we have experienced the IVDD and transition periods and have now formally entered the IVDR age. During the transition to the IVDR, we have acutely sensed the new regulation's more comprehensive and precise regulatory approach, as well as the unfamiliar or difficult-to-implement provisions.

The main criticalities generated by the current MDR framework is the requirement for brand-specific clinical studies, even when the devices in question are manufactured using the same raw materials already extensively studied in the past. This approach imposes an additional, unnecessary cost on manufacturers, who are already subject to multiple regulatory and administrative burdens.

Manufacturers of medical devices with proven technologies (especially of non-active surgical implants of class IIb and some class III products) and previous MDD 93/42/EEC certification, are struggling with the re-certification to MDR (EU) 2017/745. The complexity of CE marking for medical devices has increased significantly with the MDR.

The implementation of the Medical Device Regulation (MDR) continues to face challenges that risk undermining its intended impact on patient safety and innovation. A major concern is the insufficient capacity of Notified Bodies, which are struggling to recruit and train qualified personnel due to the specific requirements of MDR and the delayed issuance of EU guidance.

The Association of Medical Device Reprocessors, AMDR, respectfully submits feedback with regard to Article 17, or the single-use device reprocessing provisions. Consistent with this call for evidences objectives, we strongly urge the Commission to recommend a simplification of Article 17.1 to reduce the needless and disproportionate burden placed on innovative, circular reprocessed or remanufactured devices.

This feedback particularly relates to the European regulatory framework regarding digital tools as medical devices. I am providing this feedback as the Principal Investigator of the H2020 IMMERSE project, on the implementation of digital tools in clinical practice.

SME manufacturers of medical devices with proven technologies MDD 93/42/EEC to MDR (EU) 2017/745 The complexity of CE marking for medical devices has increased significantly with the MDR. The MDR requirements, together with the flood of new MDCG documents, pose a challenge for us as an SME. The entire approval process has become lengthy and costly.

1. Properly functioning CE labelled tests are taken out of production, as it is costly for manufacturers to comply with the CE IVD standard. This reduces the quality of diagnostics because alternatives are less of quality or do not exist at all. This cannot be the intention. 2. Exchange of LDTs in the absence of a CE IVD alternative (e.g. rare diseases or multicer studies) is not possible under current legislation.

Filed in Dutch · English published by the European Commission

The following cases are illustrated to explain the problem of MDR and suggestions. 1. A Class IIa spinal invasive product, which is firstly approved in 2008 under MDD, takes over 3.5 years (Aug. 2020 ~ Apr. 2024) to get its MDR CE certificate. We encounter additional on-site inspection with extra fee just because the NB itself does not make their internal process clear.

When assessing the MDR from the point of view of a small enterprise which falls within the scope of Article 14 and Article 22, we can only agree with the critical comments already received. The administrative and human resources involved, and the associated high costs of implementing the MDR, must be regarded as disproportionate to the size of the firm’s role on the market.

Filed in German · English published by the European Commission

The application of the MDR/IVDR Regulations to existing products, some of which have proved for decades that they do not pose a risk to patients, is incomprehensible. Unnecessary requirements which only serve to complete paper, but do not make the products themselves safer at all. These documents are then subject to exorbitant fees from notified bodies, which are justified by the expertise of their staff.

Filed in German · English published by the European Commission

Intended to enhance patient safety in the EU, the MDR suffers from several issues that create significant regulatory burdens and inefficiencies for manufacturers. The current regulations are marked by inconsistent guidance, rather increased by the flood of MDCG documents. This leads to uncertainty and excessive work for economic operators. A key problem is the lack of clarity and proportionality in reporting.

In my view, one of the main problems with the MDR/IVDR is that the Regulatorians apply to all medical devices without any further differentiation, including all existing products. This results in the processing backlog complained of by all the parties and the enormous administrative burden for manufacturers.

Filed in German · English published by the European Commission

I would like to provide the following feedback regarding the implementation of the Medical Device Regulation (MDR): Firstly, during clinical evaluation, auditors require manufacturers to analyze clinical benefits both quantitatively and qualitatively. However, when we asked how this should be done, the auditors refused to provide guidance, stating that they do not offer consulting services.

The biggest challenge for us is cooperation with notified bodies in Germany. There are different interpretations of the MDR both within the CB and for the different CBs. In some cases, Regulatorians are subjectively interpreted up to the smallest detail and, above all, demanded us as small businesses. There is no longer a risk-based approach, but only documentation that has no added value.

Filed in German · English published by the European Commission

Europeans for Safe Connections (ESC) fully concurs with the stated objective of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which is "to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation".

It is questionable whether the original purpose of the MDR to improve patient/product safety is fulfilled. This leads to overburdened business structures, stagnation in innovation and technological progress, to business tasks due to the high financial burden. Huge costs and human resources are spent on file and documentation, approvals, foreign registrations...

Filed in German · English published by the European Commission

As a manufacturer of medical technology on the market since 1948, it is inconceivable that the criminal activities of a French, who has used industrial silicon instead of medical silicon, are now suffering the entire medical technology industry. The French producer was controlled by TÜV Germany.

Filed in German · English published by the European Commission

As a clinical laboratory specialist, I would like to highlight an important gap in the current IVDR framework regarding the use of Laboratory-Developed Tests (LDTs) in clinical research, particularly in rare diseases such as pediatric cancers. Under the current IVDR rules, LDTs (article 5.5) may not be shared between different legal entities.

There is a risk that reduced availability of medical devices (MD/IVD) may increase the use of self-manufactured products in healthcare. This means an undesirable shift of responsibility for product safety from manufacturers to health institutions.

Filed in Swedish · English published by the European Commission

The current application of MDR Rule 11 leads to a systematic over-classification of Software as a Medical Device (SaMD). Even very low-risk applications, such as self-management or adherence apps, are routinely classified at least as Class IIa under a conservative interpretation. This contradicts the MDRs founding principles, particularly Recitals 58 and 60, which emphasize proportionality and risk-based regulation.

We are developing a new innovative medical device to help improve key areas of restorative dentistry. Our product uses the safest and highest performing oxidising disinfectant molecule, that is actually a biomimetic and produced in white blood cells. Our manufacturing partners are global leaders in the manufacture of our active and contributed technical data to the Commission/ECHA for BPR/article 95 for biocides.

We appreciate the opportunity to provide feedback on the targeted evaluation of EU rules on medical devices. This response addresses the requirement outlined in Annex VI Part C 4.10 of Regulation (EU) 2017/745 (MDR) concerning the direct marking of reusable medical devices with both Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI).

As an SME manufacturer, we experience significantly increased costs and red tape under the MDR (evidence, NB fees, PMS/PMCF), without any measurable safety gain. This is not manageable for small businesses. Please: (1) Risk-based proportionality with leaner CERs for good PMS; (2) SME facilitation (fee caps, mandatory templates, Once-Only in EUDAMED); (3) predictable NB procedures and less redundancy; (4) simplified…

Filed in German · English published by the European Commission

To whom this may concern, PHOENIX group welcomes the initiative of the European Commission to evaluate EU rules on medical devices and in vitro diagnostics. We especially welcome the focus of the evaluation on protecting patient health while making the medical device sector more agile in a challenging geopolitical environment.

The following are suggested: 1. Do not require new clinical evidence for products of established use that already have clinical evidence to support the claimed clinical benefit. The clinical benefit must of course be clearly explained. 2. Remove the constraints for gathering information from the market for PMCF of devices already CE marked used according to the intended purpose indicated by manufacturer 3.

Filed in Italian · English published by the European Commission

Our experience working with the Notified Body has been nothing short of disastrous. What should have been a structured, transparent, and collaborative process turned into a deeply frustrating ordeal. The most pressing issue was the excessive financial burden they imposedoften without clear justification, accountability, or proper checks and balances.

Contribution on the Proportional Application of IVDR to Long-Established IVD Reagents The IVDR (Regulation (EU) 2017/746) was designed to strengthen the regulatory framework for in vitro diagnostic devices and to ensure the highest standards of safety and performance.

Ladies and Gentlemen, we have already been in direct contact with the European Parliament. Please find attached correspondence. But this has not really helped us. On the one hand, the MDR is far too extensive and too detailed, but on the other hand, particularly with regard to our area, it is far too vague and, in some cases, impossible to apply and implement in practice.

Filed in German · English published by the European Commission

We are a small, family-owned enterprise with fewer than 50 employees, and have been manufacturing in vitro diagnostic devices (IVD) for several decades. Due to our long-standing experience, we possess deep and comprehensive knowledge of our products, which have consistently demonstrated to be safe and effective in daily use.

Innovation registered with ticket from Itero International Scanners Can be developed via ECHA & details we need about all kind of materials involved in the market with different qualites & toxicity levels. To include the information to computer chips as data Will empower the lamp of the scanners to analyse all details we need to know about medicinsk Devices & materials Today that Itero as a Company has all the…